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Current challenges in assessing immunogenicity.

Gopi Shankar1

  • 1Janssen Research & Development, LLC, 1400 McKean Road, Spring House, PA 19477, USA.

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|October 17, 2019
PubMed
Summary
This summary is machine-generated.

Gopi Shankar, an expert in immunogenicity, leads a department focused on biologic molecule characterization and preclinical development. His work has significantly advanced understanding and practices in clinical immunogenicity for drug development.

Keywords:
ADAanti-drug antibodiesimmunogenicity

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Area of Science:

  • Biotechnology
  • Pharmaceutical Sciences
  • Drug Development

Background:

  • Gopi Shankar is a Vice President at Janssen BioTherapeutics, overseeing a department of 150 scientists.
  • The department characterizes biophysical and pharmacological parameters of biologic molecules for discovery and preclinical development.
  • They determine pharmacokinetics, toxicokinetics, pharmacodynamics, and dose recommendations for biologics.

Discussion:

  • Dr. Shankar has consistently focused on innovative solutions to scientific challenges throughout his career.
  • He has been instrumental in developing consensus and harmonizing scientific practices within his field.
  • His expertise has led to impactful scientific advances in the area of immunogenicity.

Key Insights:

  • Dr. Shankar is a recognized expert in immunogenicity and a Fellow of the American Association of Pharmaceutical Scientists (AAPS).
  • His research, consensus-building, and publications have transformed approaches to clinical immunogenicity.
  • The department provides crucial analytical and bioanalytical data for clinical trials of biologics.

Outlook:

  • Continued focus on developing innovative solutions for scientific hurdles in biopharmaceutical development.
  • Further harmonization of scientific practices to enhance drug development efficiency.
  • Ongoing contributions to advancing the understanding and management of clinical immunogenicity.